SEC v. Stefano R. Carchedi; Marie L. Foegh Ramwell; and James G. Cullem, No. 1:25-cv-10599, District of Columbia (Mar. 12, 2025) — Complaint

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS

___________________________________________
)
SECURITIES AND EXCHANGE COMMISSION, )
)
Plaintiff,   )
)
v.      ) Case No.
)
       )
STEFANO R. CARCHEDI,     )  JURY TRIAL DEMANDED
MARIE L. FOEGH RAMWELL, and  )
JAMES G. CULLEM     )
)
Defendants.    )
___________________________________________ )

COMPLAINT

Plaintiff United States Securities and Exchange Commission (“the Commission”) alleges:
SUMMARY
1. From February 2020 to February 2022, three senior executives of Massachusetts-
based Allarity Therapeutics, Inc. (“Allarity” or the “Company”), Stefano Carchedi, Marie Foegh
Ramwell (“Foegh”), and James Cullem (collectively, the “Defendants”), schemed to conceal
from investors a harsh critique levied by the Food and Drug Administration (“FDA”) about the
approval prospects for Allarity’s flagship cancer drug candidate, dovitinib.  Specifically, in
February 2020, the FDA recommended that Allarity not submit its proposed drug application
seeking approval to market and sell dovitinib, because the data was insufficient, and instead
conduct a new drug trial—something Allarity had no intention of doing.
2. Defendants each knew, or were reckless in not knowing, that dovitinib would not
be approved for sale to the public absent a new drug trial. Despite that, Defendants hid the

2
FDA’s admonitions from investors and more broadly.  In addition, Carchedi propagated false
and misleading claims about dovitinib’s efficacy and likelihood of approval in Allarity’s efforts
to raise money from investors to stay afloat.
3. Ultimately, Allarity submitted its flawed drug application to the FDA on
December 21, 2021, without conducting a new trial as recommended by the FDA. Allarity’s
press release announcing the submission of its drug application did not disclose that the FDA had
advised against the submission.
4. The same day Allarity submitted its drug application, Allarity announced that it
had listed its stock on the NASDAQ stock exchange and secured a $20 million investment from
a single investor, largely premised on Allarity having a viable drug application for dovitinib.
That investor, like the public, was unaware that dovitinib had virtually no chance of approval
absent a new trial.
5. Then, on February 18, 2022, Allarity revealed for the first time a problem with its
drug application, announcing that the FDA had refused to even review the application—a drastic
measure by FDA standards. The next trading day, Allarity’s share price closed down
approximately 31%.
6. By knowingly, recklessly, or negligently engaging in the conduct described in this
Complaint, Carchedi violated Section 17(a) of the Securities Act of 1933 (“Securities Act”) and
Section 10(b) of the Securities Exchange Act of 1934 (“Exchange Act”) and Rule 10b-5
thereunder, and Cullem and Foegh violated Sections 17(a)(1) and (3) of the Securities Act and
Section 10(b) of the Exchange Act and Rules 10b-5(a) and (c) thereunder.

3
7. The Commission seeks (a) a permanent injunction prohibiting the Defendants
from directly or indirectly engaging in the conduct described herein, or in conduct of similar
purport and effect; (b) disgorgement plus pre-judgment interest; (c) civil penalties; and (d)
officer and director bars.
JURISDICTION AND VENUE
8. The Court has jurisdiction over this action pursuant to Sections 20(d) and 22(a) of
the Securities Act [15 U.S.C. §§77t(d), 77v(a)], and Sections 21(d), 21(e) and 27 of the
Exchange Act [15 U.S.C. §§78u(d), 78u(e), 78aa].
9. Venue is proper in this District because Allarity maintained an office in
Massachusetts since at least October 2020 and, at all relevant times, Allarity conducted business
in Massachusetts and Cullem lived in Massachusetts.  A substantial part of the actions that give
rise to the Commission’s claims also occurred in Massachusetts.
10. In connection with the acts described in this Complaint, Defendants directly or
indirectly made use of the mails or the means or instruments of transportation or communication
in interstate commerce.
11. Defendants’ conduct involved fraud, deceit, or deliberate or reckless disregard of
regulatory requirements, and resulted in substantial loss, or significant risk of substantial loss, to
other persons.
DEFENDANTS
12. Stefano R. Carchedi (“Carchedi”), age 63, was the chief executive officer, the
president, and a board member for Allarity or its predecessor from September 2019 to June 2022,

4
when he was terminated for conduct related to the allegations in this Complaint.  Before joining
Allarity, Carchedi worked in various senior positions, including as CEO, for numerous
pharmaceutical companies since 1989.  Currently, he serves as chairman of the board for a
privately held manufacturer of laboratory equipment for the life sciences industry.  Carchedi is a
resident of Lower Gwynedd, Pennsylvania.
13. Marie L. Foegh Ramwell (“Foegh”), age 82, was the chief medical officer of
Allarity or its predecessor from May 2017 to March 2024.  She is presently employed as a
physician in Denmark and as an independent pharmaceutical consultant and expert witness.  She
also currently serves as chairman of the board of a Danish pharmaceutical packaging company.
She is licensed as a medical doctor in the District of Columbia, Maryland, and Virginia. Foegh is
a resident of New York, New York, East Patchogue, New York and Denmark.
14. James G. Cullem (“Cullem”), age 56, was Allarity’s chief executive officer
from June 2022 to December 2023.  He was also the chief business officer from December 2021
to June 2022, the senior vice president of corporate development from October 2019 to
December 2021, and a board member from June 2022 to January 2024 for Allarity and/or its
predecessor.  Presently, he runs his own consulting firm to the life sciences industry.  He is a
licensed attorney in Massachusetts and a resident of Newburyport, Massachusetts.
RELEVANT ENTITY
15. Allarity Therapeutics, Inc., (“Allarity”), a Delaware corporation, is a small
biopharmaceutical company whose principal place of business is in Boston, Massachusetts.
From at least October 2020 to the present, Allarity maintained a U.S. office in Massachusetts.
Before October 2020, Allarity maintained a U.S. office in Scottsdale, Arizona.  Allarity’s

5
common stock is registered with the Commission under Section 12(b) of the Exchange Act and
has traded on the NASDAQ stock exchange under the symbol “ALLR” since December 21,
2021.  Prior to incorporating in Delaware and registering its stock with the Commission, Allarity
was a Danish company and operated under the names Oncology Venture A/S and Allarity
Therapeutics A/S, both of which traded on a Swedish stock exchange.
STATEMENT OF FACTS
The FDA Approval Process
16. Before a drug can be marketed and sold in the U.S., a drug company must obtain
approval from the FDA.  According to the FDA, it will only approve a drug if it is safe and there
is “substantial evidence” consisting of “adequate and well-controlled” trials demonstrating that
the drug is effective for its intended use in humans.
17. To demonstrate the safety and efficacy of a drug, pharmaceutical companies
conduct human clinical trials in three phases.  Phase III trials, the largest and most expensive of
the three phases, are supposed to provide sufficient evidence of efficacy and safety to enable the
FDA to evaluate the overall risk-benefit relationship of the drug.
18. Drug trials can be “superiority” trials (which seek to demonstrate that the test
drug is more effective than the comparison drug) or “non-inferiority” trials (which seek to
demonstrate that the efficacy of the test drug is within a clinically acceptable margin (the “non-
inferiority margin”) of the efficacy of the comparison drug).  Per published FDA guidance, this
“non-inferiority margin” must be specified before the trial begins to avoid the potential bias
created by already knowing the trial results when the non-inferiority margin is set.

6
19. Typically, clinical trials for cancer drugs, like dovitinib, measure efficacy in terms
of (1) overall survival (“OS”) (the length of time from the start of treatment to patient death) or
(2) progression-free survival (“PFS”) (the length of time from the start of treatment to the earlier
of tumor growth or patient death).  Assessing tumor growth, and thus PFS, requires more
subjectivity on the part of the investigator than OS; consequently, FDA guidance states that OS
is the optimal endpoint.
20. If a pharmaceutical company believes it has generated sufficient evidence of
safety and efficacy, it may seek approval to market and sell its drug to the public.  It does so by
submitting a New Drug Application (“NDA”) to the FDA.
21. Within 60 days of a company submitting an NDA, the FDA must either “file” the
NDA, meaning the FDA deems it sufficiently complete to permit a substantive review, or issue a
Refusal to File (“RTF”) letter.  An RTF letter is typically reserved for circumstances where the
NDA is incomplete, because it does not on its face contain certain required information, or where
the required content is presented in an unusable form. An RTF also may be warranted when a
single trial underpins a submitted NDA, but the FDA has advised the drug company previously
that more than one trial would be required.
Dovitinib’s Success was Material to Allarity
22. Allarity is a biopharmaceutical company focused on pairing cancer drug
candidates that have been abandoned or shelved by other companies with a genetic test Allarity
developed, thus targeting patients most likely to benefit from a particular cancer drug.  One such
drug candidate was dovitinib.

7
23.  Dovitinib originally was developed by another pharmaceutical company,
Company A, for the treatment of advanced renal cell carcinoma, a particularly deadly form of
kidney cancer.  Company A ceased developing dovitinib after a 2013 Phase III trial failed to
show that dovitinib was more effective than (or superior to) a comparator drug (“the Dovitinib
Trial”).  In 2018, Allarity licensed dovitinib from Company A.
24. Dovitinib’s hoped-for approval by the FDA was material to Allarity because the
company had yet to have a drug approved for sale to the public.  As a result, at all relevant times,
the estimated likelihood of dovitinib’s success factored heavily into Allarity’s business
prospects.  As Allarity itself acknowledged in 2021 public filings with the Commission, “[i]f we
are unable to submit an NDA to the U.S. FDA for our therapeutic candidate dovitinib... or if we
experience significant delays in doing so,” or “[i]f we are unable to... receive marketing
approval for... dovitinib...our business could be substantially harmed.”
Allarity is Admonished by the FDA
25. In December 2019, Allarity requested a meeting with FDA staff to discuss
Allarity’s analysis of the Dovitinib Trial data and the anticipated filing of the dovitinib NDA (the
“FDA Meeting”).
26. In correspondence ahead of the FDA Meeting, Allarity communicated to the FDA
its plan to rely on a retrospective, non-inferiority analysis of PFS from the Dovitinib Trial and
solicited the FDA’s feedback on various questions.  Although this plan contravened published
FDA guidance, Allarity chose to rely on a non-inferiority analysis of PFS because the Dovitinib
Trial had already failed to show dovitinib was superior to the comparator drug on either PFS or
OS.

8
27. The FDA staff responded in writing on February 14, 2020, saying in the preamble
of the written comments: “We do not agree with your plan to submit an NDA based on a
retrospective non-inferiority analysis of a trial that failed to demonstrate superiority.  There are
multiple issues with your proposal...”  The specific issues the FDA noted were Allarity’s
proposal to 1) define the non-inferiority margin for its analysis after the Dovitinib Trial had
already concluded and 2) analyze PFS rather than OS.  The FDA took issue with Allarity’s
analysis because it was susceptible to manipulation for two reasons: one, Allarity was proposing
to define the non-inferiority margin for its analysis after it already knew the results of the
Dovitinib Trial; and two, Allarity was planning to assess the more subjective of the two study
endpoints, PFS (rather than OS).
28.  In responding to Allarity’s question, “Does the Agency agree that the proposed
clinical data supporting the proposed safety and efficacy claims are adequate to support the
submission of the NDA for the proposed indication?” the FDA responded, “No,” and referenced
the preamble again.  In response to another Allarity question, “Does the Agency agree that this
statistical approach is adequate to support the filing of dovitinib in the proposed indication?” the
FDA also responded, “No.”
29. For all eleven written questions posed by Allarity to the FDA, the FDA referenced
back to the preamble in their responses, putting Allarity on notice that the FDA was highly
unlikely to even accept the dovitinib NDA for substantive review, much less approve it.
30. Carchedi, Foegh and Cullem each received a copy of the FDA’s written response
on February 14, 2020.
31. The next day, Allarity’s Chief Science Officer emailed Carchedi and Foegh to

9
note that the FDA’s published guidance referenced in the FDA’s written response to Allarity
appeared to be an “insurmountable hurdle” because it prohibited the exact analysis Allarity
planned to use as the basis for the dovitinib NDA.
32. On February 20, 2020, Allarity and FDA staff met in person.  Carchedi and Foegh
attended the FDA Meeting along with various consultants Allarity had retained to advise it on its
regulatory strategy.
33. The official minutes of the FDA Meeting, which were created by FDA staff
during the meeting, with Allarity employees and consultants present, summarized the parties’
main discussion points.  The minutes stated, in relevant part, “FDA reiterated that unplanned
determination of non-inferiority following failure to show superiority would not suffice for
demonstrating non-inferiority of dovitinib and that PFS is not an appropriate endpoint for a non-
inferiority trial.  The FDA recommended that [Allarity] prospectively plan and conduct a new
trial”—the strongest language the FDA uses in meeting minutes.
34. Foegh, Carchedi, and Cullem each received a copy of the official meeting minutes
on March 18, 2020.  In an email to an Allarity consultant, Foegh described the minutes as “pretty
negative in terms of filing” with “[n]early every answer to our questions [beginning] with Do not
file the NDA.”
35. Allarity’s consultants who attended the FDA Meeting took notes of their own.
These notes also reflected the grim outcome of the FDA Meeting.  One set of notes
memorialized that:
a. “FDA essentially claimed that there was simply no efficacy (or, insufficient
efficacy) with dovitinib”
b. “sounded like FDA doesn’t want to see dovitinib get on the market,”
c. “Several different times, and in different ways, FDA reiterated that the ‘non-

10
inferiority approach’...was invalid....FDA further stated that the ‘use’ of PFS
and the definition of disease progression was invalid for / impossible to use
with an NI approach.”
d. “the possible submission of an NDA was ‘delaying the inevitable.’”

Foegh and Cullem received a copy of these notes on February 20, 2020, and February 22, 2020,
respectively.
36. A different consultant’s notes observed that:
a. “FDA reiterated its position that the trial that the NDA is based upon did not
demonstrate superiority and that [Allarity] cannot now use the data and apply
it to non-inferiority trial.” [emphasis in original],
b. “the [FDA] is asking [Allarity] not to submit the NDA,” and
c. “FDA stated that they do not currently advise submitting an application[.]”
Carchedi and Foegh received these notes on or about March 11, 2020.
Defendants Schemed to Hide the FDA’s Recommendations
37. Allarity issued a press release on March 20, 2020, purporting to update the public,
including investors, on the outcome of the FDA Meeting.  Carchedi, Foegh and Cullem helped
draft the press release, and Carchedi approved it.  The press release remained on Allarity’s public
website through at least 2022.
38. This press release painted a wholly inaccurate and incomplete picture of the FDA
Meeting.  One, it falsely claimed, “FDA indicated that they would accept the [New Drug
Application] filing if submitted, and provided additional guidance regarding the submission[.]”
In actuality, Defendants knew, or were reckless in not knowing, the FDA had recommended
against submitting the dovitinib NDA and had threatened not to accept it for filing.
39. Two, the press release represented that: “[Allarity] plans to use the data from the
[Dovitinib Trial] to prove that Dovitinib is in fact ‘non-inferior’ to [the comparison drug] for the
treatment of [renal cell carcinoma], and expects that Dovitinib will be approved by the FDA as a

11
safe and efficacious drug[.]”  This statement was false and misleading because Defendants knew,
or were reckless in not knowing, that the FDA had outright rejected this plan and that dovitinib
would not be approved on such data.
40. Three, the press release stated that the FDA has “provided input on the ‘non-
inferiority’ margin” and “discussed progression free survival (PFS) as an endpoint for ‘non-
inferiority,’” but misleadingly omitted FDA’s actual input— i.e., that Allarity’s proposed
analysis was invalid and unusable.
41. Finally, the March 20, 2020, press release was misleading because it did not
disclose the crux of the FDA’s feedback—the recommendation that Allarity conduct a new trial
prior to submitting its NDA.  By omitting this information, Defendants misrepresented the
strength of the dovitinib NDA and its likelihood of approval.
42. Carchedi, Cullem and Foegh also misled Allarity’s Board of Directors.  On March
30, 2020, only twelve days after Defendants received a copy of the strident FDA meeting
minutes, Allarity’s Board met.
43. Carchedi presented at the Board meeting.  According to the Board minutes,
Carchedi falsely characterized the FDA Meeting as “positive”— withholding from the Board the
FDA’s admonishment not to submit the dovitinib NDA and instead conduct a new trial. Cullem
also attended the Board meeting as secretary, but did not disagree with Carchedi’s
characterization or disclose the FDA’s actual feedback to the Board.
44. Defendants were all regular presenters at Board meetings thereafter.  However, at
no point before filing the dovitinib NDA in December 2021 did any of the Defendants alert the
Board to the FDA’s forceful criticisms, despite dovitinib’s undeniable importance to Allarity’s

12
business prospects.
45. Defendants’ deception also extended to Company A, from which it had licensed
dovitinib and which had signed a non-disclosure agreement with Allarity.  On February 16,
2021, Company A requested a copy of the FDA Meeting minutes.  Rather than provide Company
A with an unadulterated copy of the minutes pursuant to the non-disclosure agreement in place,
Carchedi and Cullem undertook to redact any negative information from the minutes.  When
Cullem circulated the proposed redactions internally on March 5, 2021, he explained, “I have
redacted (blackout text) any of the FDA comments about unwillingness to accept non-inferiority
etc.”  Cullem then sent Company A the heavily redacted version of the minutes on March 18,
2021, copying Foegh.
46. On August 23, 2021 and November 23, 2021, Allarity published on its website
two “Interim reports,” one of which it also filed with the SEC, for the purpose of disclosing
information about its proposed move from Denmark to the U.S. and the exchange of shares
traded on the Swedish stock exchange for shares that would trade on the NASDAQ.  Carchedi
helped draft, and signed, both reports.
47. In the Interim reports, Allarity misrepresented that the FDA Meeting “provided
guidance to the Company regarding its potential path to approval” and “[b]ased on this feedback
from the FDA, Allarity plans to file a New Drug Application (“NDA”) for the approval of
dovitinib . . .  during 2021” (emphasis added).  This was misleading because the FDA’s feedback
had been not to submit the dovitinib NDA but instead to conduct a new trial.
48. The interim reports also misrepresented dovitinib as having “shown identical
clinical activity to [the comparator drug]” in the Dovitinib Trial.  This claim was misleading for

13
three reasons: 1) Allarity’s post-hoc, non-inferiority analysis of the Dovitinib Trial did not even
assess whether dovitinib had “identical clinical activity” to the comparator drug —a more
exacting standard than non-inferiority; 2) it omitted that the Dovitinib Trial had failed to show
dovitinib was superior to the comparator drug on either PFS or OS; and 3) it neglected to
disclose that the FDA had rejected Allarity’s proposal to use the Dovitinib Trial to demonstrate
dovitinib’s efficacy.
49. In anticipation of listing Allarity stock on NASDAQ, on November 4, 2021,
Allarity filed with the Commission a Form S-4 Registration Statement containing a prospectus.
On December 16, 2021, Allarity filed with the Commission a Form S-1 Registration Statement
containing a prospectus in connection with a $20 million investment from an investor, allowing
that investor to offer and sell the Allarity shares it would receive in exchange for its investment
in Allarity.  Carchedi signed both prospectuses.
50. Both prospectuses touted dovitinib’s purported “therapeutic equivalence to” the
already-approved comparison drug and claimed the Dovitinib Trial had “established that
dovitinib is non-inferior to [the comparison drug] with respect to PFS and OS.”  This was
misleading because Defendants knew, or were reckless in not knowing, that the FDA disagreed
with these efficacy claims.
51. Further, the December 16 prospectus provided the false assurance that “we
anticipate...approval of our [NDA].”  Defendants knew, or were reckless in not knowing, that
the dovitinib NDA would not be approved absent a new trial because the FDA had previously
told Allarity that it did not agree with Allarity’s plan to submit an NDA based on a retrospective
non-inferiority analysis of the Dovitinib Trial.  This same prospectus also listed the FDA’s

14
requirements for drug approval based on retrospective analyses, but misleadingly failed to
mention that the FDA had told Allarity that the proposed dovitinib NDA had not met such
requirements.
52. Throughout 2021, Allarity maintained and periodically updated a slide deck that
Carchedi used in discussions with investors and prospective investors.  The Defendants each
participated in preparing the deck.  In this slide deck, which was posted to Allarity’s website and
filed with the Commission as an exhibit to Form 8-K on January 18, 2022, Allarity falsely
claimed dovitinib’s efficacy had been demonstrated in a Phase III trial.  This was false and
misleading because the FDA expressly advised Allarity that the Dovitinib Trial could not be used
to demonstrate dovitinib’s efficacy for purposes of approval.
53. The slide deck also misleadingly touted that the dovitinib NDA had selected renal
cell carcinoma as the lead indication “. . . for fastest path to approval” (emphasis in original) of
the dovitinib NDA, but omitted the FDA’s recommendation not to submit the dovitinib NDA at
all and to instead conduct a new trial.
54. Allarity provided a copy of the slide deck to a prospective investor in March
2021, and to at least two prospective investors in October 2021.  Allarity ultimately raised $20
million in December 2021 from a single investor in connection with these prospectuses and slide
decks.
Defendants Capitalize on the NDA Submission
55. On December 21, 2021, Allarity submitted its NDA for dovitinib.  The NDA did
not contain data from any second trial, as recommended by the FDA, and was premised on an
after-the-fact, non-inferiority analysis of the Dovitinib Trial, which the FDA had warned Allarity

15
against using.  Nevertheless, the press release Allarity issued on December 22, 2021, heralding
the milestone did not disclose the FDA’s prior criticisms of the data, its admonishment not to
submit the NDA, or its recommendation to conduct a new trial. Carchedi gave the final approval
on this press release.
56. Also on December 21, 2021, Allarity announced that it had secured $20 million in
funding from a single investor and that its stock had begun trading on NASDAQ.
57. For meeting certain goals, including submitting the dovitinib NDA and listing
Allarity’s stock on the NASDAQ by the end of 2021, the Allarity Board awarded Carchedi a
cash bonus of approximately $225,000, Foegh a cash bonus of approximately $132,000, and
Cullem a cash bonus of approximately $119,000. All three also received stock option awards.
Defendants’ Scheme Unravels
58. On January 27, 2022, FDA staff and Allarity met by phone.  Foegh participated in
the call.  Referring back to its statements from the FDA Meeting, FDA staff again advised
Allarity that the dovitinib NDA was riddled with issues—each of which would render it
unapprovable—and recommended Allarity withdraw the NDA. Allarity did not withdraw its
NDA, but never disclosed to investors that the FDA had recommended withdrawal.  Carchedi
and Cullem were informed of the outcome of the call later the same day.
59. Then, on February 15, 2022, the FDA issued Allarity an RTF letter.  According to
the letter, FDA declined to proceed with a substantive review of the dovitinib NDA because a
retrospective, non-inferiority analysis of a failed superiority trial cannot be used to demonstrate
PFS—the same warning the FDA had communicated to Allarity years before, at the in-person
FDA Meeting in 2020.

16
60. When Allarity’s Chairman of the Board received a copy of the RTF letter, on or
about February 18, 2022, he emailed Cullem saying, “I’m interested to know who advised us to
file against the crystal clear advice of the FDA.”  Cullem and Carchedi explained in response
that securing the $20 million investment in December 2021 had been crucial to Allarity avoiding
bankruptcy and filing the NDA had been crucial to the investor providing funding.
61. On February 18, 2022, Allarity, for the first time, publicly revealed a problem
with its NDA, announcing its receipt of the RTF letter.  The press release, which was drafted, in
part, by Carchedi and Cullem and approved by Carchedi, again concealed from investors that the
FDA had threatened Allarity with this very outcome years before, in 2020.
62. The next trading day the market reacted strongly, with Allarity’s stock price
closing down approximately 31%—the largest one-day drop in the stock’s history up to that
point.
63. Then, in August 2022, Allarity announced it was no longer pursuing development
of dovitinib as a stand-alone treatment for kidney cancer.
FIRST CLAIM
Fraud in the Purchase or Sale of Securities in Violation of
Section 10(b) of the Exchange Act and Rule 10b-5 Thereunder
(Against Carchedi)
64. The Commission repeats and incorporates by reference the allegations in
paragraphs 1- 63 above as if set forth fully herein.
65. Carchedi engaged in a fraudulent course of conduct that included making material
misrepresentations and omitting to state material facts necessary to make the statements made, in
light of the circumstances under which they were made, not misleading regarding an FDA

17
recommendation not to submit an NDA for dovitinib.
66. By engaging in the conduct described above, Carchedi, directly or indirectly,
acting knowingly or recklessly, by the use of means or instrumentalities of interstate commerce
or of the mails, in connection with the purchase or sale of securities, has employed devices,
schemes or artifices to defraud; made untrue statements of material fact or omitted to state
material facts necessary to make the statements made, in light of the circumstances under which
they were made, not misleading; and engaged in acts, practices or courses of business which
operate as a fraud or deceit upon certain persons.
67. By reason of the forgoing, Carchedi violated Section 10(b) of the Exchange Act
[15 U.S.C. §78j(b)] and Rule 10b-5 thereunder [17 C.F.R. §240.10b-5].
SECOND CLAIM
Fraud in the Offer or Sale of Securities in
Violation of Section 17(a) of the Securities Act
(Against Carchedi)
68. The Commission repeats and incorporates by reference the allegations in
paragraphs 1-63 above as if set forth fully herein.
69. Carchedi engaged in a fraudulent course of conduct that included making material
misrepresentations and omitting to state material facts necessary to make the statements made, in
light of the circumstances under which they were made, not misleading regarding an FDA
recommendation not to submit an NDA for dovitinib.
70. By engaging in the conduct described above, Carchedi, directly or indirectly,
acting knowingly, recklessly, or negligently, in the offer or sale of securities by the use of means
or instrumentalities of interstate commerce or the mails, has employed devices, schemes or

18
artifices to defraud; obtained money or property by means of untrue statements of material fact
or the omission of a material fact necessary in order to make the statements, in light of the
circumstances under which they were made, not misleading; and engaged in transactions,
practices or courses of business which operate as a fraud or deceit upon purchasers of the
securities.
71. By reason of the forgoing, Carchedi violated Section 17(a) of the Securities Act
[15 U.S.C. §77q(a)].
THIRD CLAIM
Fraud in the Offer or Sale of Securities in
Violation of Sections 17(a)(1) and (3) of the Securities Act
(Against Cullem and Foegh)
72. The Commission repeats and incorporates by reference the allegations in
paragraphs 1-63 above as if set forth fully herein.
73. Cullem and Foegh engaged in a fraudulent course of conduct regarding an FDA
recommendation not to submit an NDA for dovitinib.
74. By engaging in the conduct described above, Cullem and Foegh, directly or
indirectly, acting knowingly, recklessly, or negligently, in the offer or sale of securities by the
use of means or instrumentalities of interstate commerce or the mails, have employed devices,
schemes or artifices to defraud; and engaged in transactions, practices or courses of business
which operate as a fraud or deceit upon purchasers of the securities.
75. By reason of the forgoing, Cullem and Foegh violated Sections 17(a)(1) and (3) of
the Securities Act [15 U.S.C. §77q(a)(1) and (3)].

19
FOURTH CLAIM
Fraud in the Purchase or Sale of Securities in
Violation of Section 10(b) of the Exchange Act and Rules 10b-5(a) and (c) Thereunder
(Against Cullem and Foegh)
76. The Commission repeats and incorporates by reference the allegations in
paragraphs 1-63 above as if set forth fully herein.
77. Cullem and Foegh engaged in a fraudulent course of conduct regarding an FDA
recommendation not to submit an NDA for dovitinib.
78. By engaging in the conduct described above, Cullem and Foegh, directly or
indirectly, acting knowingly or recklessly, in connection with the purchase or sale of securities,
by the use of means and instrumentalities of interstate commerce, or of the mails, or of a national
securities exchange have employed devices, schemes or artifices to defraud and have engaged in
acts, practices or courses of business which operate as a fraud or deceit upon certain persons.
79. By reason of the forgoing, Cullem and Foegh violated Section 10(b) of the
Exchange Act [15 U.S.C. §78j(b)] and Rules 10b-5(a) and (c) thereunder [17 C.F.R. §240.10b-
5(a) and (c)].
PRAYER FOR RELIEF
WHEREFORE, the Commission requests that this Court:
A. Enter a permanent injunction restraining Defendants and each of their agents,
servants, employees and attorneys and those persons in active concert or participation with them
who receive actual notice of the injunction by personal service or otherwise, including facsimile
transmission or overnight delivery service, from directly or indirectly engaging in the conduct
described above, or in conduct of similar purport and effect;
B. Require Defendants to disgorge their ill-gotten gains, plus pre-judgment interest;

20
C. Require Defendants to pay an appropriate civil monetary penalty pursuant to
Section 20(d) of the Securities Act [15 U.S.C. §77t(d)], and Section 21(d)(3) of the Exchange
Act [15 U.S.C. §78u(d)(3)];
D. Impose an officer and director bar against Defendants pursuant to Section 20(e) of
the Securities Act [15 U.S.C. §77t(e)] and Section 21(d)(2) of the Exchange Act [15 U.S.C. §
78u(d)(2)];
E. Retain jurisdiction over this action to implement and carry out the terms of all
orders and decrees that may be entered; and
F. Award such other and further relief as the Court deems just and proper.

              Respectfully submitted,
SECURITIES AND EXCHANGE COMMISSION
By its attorneys,

/s/ Susan R. Cooke
Susan R. Cooke (DC Bar No. 978173)
David Fox (DC Bar No. 1686020
Dawn Edick (Mass. BBO No. 641659)
Attorneys for Plaintiff
SECURITIES AND EXCHANGE COMMISSION
33 Arch Street, 24th Floor
Boston, MA  02110
(617) 573-4538 (Cooke direct)
(617) 573-4590 (fax)
[email protected] (Cooke email)

DATED: March 12, 2025

21
CERTIFICATE OF SERVICE

 I, Susan Cooke, hereby certify that this document was filed on this date through the ECF
system and will be sent to the registered participants as identified on the Notice of Electronic
Filing (NEF) as of the date of this filing.
      /s/ Susan R. Cooke

Dated:  March 12, 2025

UNITED STATES DISTRICT COURT 

DISTRICT OF MASSACHUSETTS 

 

___________________________________________ 

) 

SECURITIES AND EXCHANGE COMMISSION, ) 

) 

Plaintiff,   ) 

) 

v.      ) Case No. 

) 

       ) 

STEFANO R. CARCHEDI,     )  JURY TRIAL DEMANDED 

MARIE L. FOEGH RAMWELL, and  )  

JAMES G. CULLEM     ) 

) 

Defendants.    ) 

___________________________________________ ) 

 

 

COMPLAINT 

 

Plaintiff United States Securities and Exchange Commission (“the Commission”) alleges:  

SUMMARY  

1. From February 2020 to February 2022, three senior executives of Massachusetts-

based Allarity Therapeutics, Inc. (“Allarity” or the “Company”), Stefano Carchedi, Marie Foegh 

Ramwell (“Foegh”), and James Cullem (collectively, the “Defendants”), schemed to conceal 

from investors a harsh critique levied by the Food and Drug Administration (“FDA”) about the 

approval prospects for Allarity’s flagship cancer drug candidate, dovitinib.  Specifically, in 

February 2020, the FDA recommended that Allarity not submit its proposed drug application 

seeking approval to market and sell dovitinib, because the data was insufficient, and instead 

conduct a new drug trial—something Allarity had no intention of doing.   

2. Defendants each knew, or were reckless in not knowing, that dovitinib would not 

be approved for sale to the public absent a new drug trial. Despite that, Defendants hid the 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 1 of 21



 

 

2 

FDA’s admonitions from investors and more broadly.  In addition, Carchedi propagated false 

and misleading claims about dovitinib’s efficacy and likelihood of approval in Allarity’s efforts 

to raise money from investors to stay afloat.   

3. Ultimately, Allarity submitted its flawed drug application to the FDA on 

December 21, 2021, without conducting a new trial as recommended by the FDA. Allarity’s 

press release announcing the submission of its drug application did not disclose that the FDA had 

advised against the submission.   

4. The same day Allarity submitted its drug application, Allarity announced that it 

had listed its stock on the NASDAQ stock exchange and secured a $20 million investment from 

a single investor, largely premised on Allarity having a viable drug application for dovitinib.  

That investor, like the public, was unaware that dovitinib had virtually no chance of approval 

absent a new trial.   

5. Then, on February 18, 2022, Allarity revealed for the first time a problem with its 

drug application, announcing that the FDA had refused to even review the application—a drastic 

measure by FDA standards. The next trading day, Allarity’s share price closed down 

approximately 31%.   

6. By knowingly, recklessly, or negligently engaging in the conduct described in this 

Complaint, Carchedi violated Section 17(a) of the Securities Act of 1933 (“Securities Act”) and 

Section 10(b) of the Securities Exchange Act of 1934 (“Exchange Act”) and Rule 10b-5 

thereunder, and Cullem and Foegh violated Sections 17(a)(1) and (3) of the Securities Act and 

Section 10(b) of the Exchange Act and Rules 10b-5(a) and (c) thereunder.   

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 2 of 21



 

 

3 

7. The Commission seeks (a) a permanent injunction prohibiting the Defendants 

from directly or indirectly engaging in the conduct described herein, or in conduct of similar 

purport and effect; (b) disgorgement plus pre-judgment interest; (c) civil penalties; and (d) 

officer and director bars.  

JURISDICTION AND VENUE 

8. The Court has jurisdiction over this action pursuant to Sections 20(d) and 22(a) of 

the Securities Act [15 U.S.C. §§77t(d), 77v(a)], and Sections 21(d), 21(e) and 27 of the 

Exchange Act [15 U.S.C. §§78u(d), 78u(e), 78aa].   

9. Venue is proper in this District because Allarity maintained an office in 

Massachusetts since at least October 2020 and, at all relevant times, Allarity conducted business 

in Massachusetts and Cullem lived in Massachusetts.  A substantial part of the actions that give 

rise to the Commission’s claims also occurred in Massachusetts. 

10. In connection with the acts described in this Complaint, Defendants directly or 

indirectly made use of the mails or the means or instruments of transportation or communication 

in interstate commerce. 

11. Defendants’ conduct involved fraud, deceit, or deliberate or reckless disregard of 

regulatory requirements, and resulted in substantial loss, or significant risk of substantial loss, to 

other persons. 

DEFENDANTS 

12. Stefano R. Carchedi (“Carchedi”), age 63, was the chief executive officer, the 

president, and a board member for Allarity or its predecessor from September 2019 to June 2022, 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 3 of 21



 

 

4 

when he was terminated for conduct related to the allegations in this Complaint.  Before joining 

Allarity, Carchedi worked in various senior positions, including as CEO, for numerous 

pharmaceutical companies since 1989.  Currently, he serves as chairman of the board for a 

privately held manufacturer of laboratory equipment for the life sciences industry.  Carchedi is a 

resident of Lower Gwynedd, Pennsylvania.    

13. Marie L. Foegh Ramwell (“Foegh”), age 82, was the chief medical officer of 

Allarity or its predecessor from May 2017 to March 2024.  She is presently employed as a 

physician in Denmark and as an independent pharmaceutical consultant and expert witness.  She 

also currently serves as chairman of the board of a Danish pharmaceutical packaging company.  

She is licensed as a medical doctor in the District of Columbia, Maryland, and Virginia. Foegh is 

a resident of New York, New York, East Patchogue, New York and Denmark.   

14. James G. Cullem (“Cullem”), age 56, was Allarity’s chief executive officer 

from June 2022 to December 2023.  He was also the chief business officer from December 2021 

to June 2022, the senior vice president of corporate development from October 2019 to 

December 2021, and a board member from June 2022 to January 2024 for Allarity and/or its 

predecessor.  Presently, he runs his own consulting firm to the life sciences industry.  He is a 

licensed attorney in Massachusetts and a resident of Newburyport, Massachusetts.     

RELEVANT ENTITY 

15. Allarity Therapeutics, Inc., (“Allarity”), a Delaware corporation, is a small 

biopharmaceutical company whose principal place of business is in Boston, Massachusetts.  

From at least October 2020 to the present, Allarity maintained a U.S. office in Massachusetts.  

Before October 2020, Allarity maintained a U.S. office in Scottsdale, Arizona.  Allarity’s 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 4 of 21



 

 

5 

common stock is registered with the Commission under Section 12(b) of the Exchange Act and 

has traded on the NASDAQ stock exchange under the symbol “ALLR” since December 21, 

2021.  Prior to incorporating in Delaware and registering its stock with the Commission, Allarity 

was a Danish company and operated under the names Oncology Venture A/S and Allarity 

Therapeutics A/S, both of which traded on a Swedish stock exchange. 

STATEMENT OF FACTS 

The FDA Approval Process  

16. Before a drug can be marketed and sold in the U.S., a drug company must obtain 

approval from the FDA.  According to the FDA, it will only approve a drug if it is safe and there 

is “substantial evidence” consisting of “adequate and well-controlled” trials demonstrating that 

the drug is effective for its intended use in humans.   

17. To demonstrate the safety and efficacy of a drug, pharmaceutical companies 

conduct human clinical trials in three phases.  Phase III trials, the largest and most expensive of 

the three phases, are supposed to provide sufficient evidence of efficacy and safety to enable the 

FDA to evaluate the overall risk-benefit relationship of the drug. 

18. Drug trials can be “superiority” trials (which seek to demonstrate that the test 

drug is more effective than the comparison drug) or “non-inferiority” trials (which seek to 

demonstrate that the efficacy of the test drug is within a clinically acceptable margin (the “non-

inferiority margin”) of the efficacy of the comparison drug).  Per published FDA guidance, this 

“non-inferiority margin” must be specified before the trial begins to avoid the potential bias 

created by already knowing the trial results when the non-inferiority margin is set.  

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 5 of 21



 

 

6 

19. Typically, clinical trials for cancer drugs, like dovitinib, measure efficacy in terms 

of (1) overall survival (“OS”) (the length of time from the start of treatment to patient death) or 

(2) progression-free survival (“PFS”) (the length of time from the start of treatment to the earlier 

of tumor growth or patient death).  Assessing tumor growth, and thus PFS, requires more 

subjectivity on the part of the investigator than OS; consequently, FDA guidance states that OS 

is the optimal endpoint.  

20. If a pharmaceutical company believes it has generated sufficient evidence of 

safety and efficacy, it may seek approval to market and sell its drug to the public.  It does so by 

submitting a New Drug Application (“NDA”) to the FDA.   

21. Within 60 days of a company submitting an NDA, the FDA must either “file” the 

NDA, meaning the FDA deems it sufficiently complete to permit a substantive review, or issue a 

Refusal to File (“RTF”) letter.  An RTF letter is typically reserved for circumstances where the 

NDA is incomplete, because it does not on its face contain certain required information, or where 

the required content is presented in an unusable form. An RTF also may be warranted when a 

single trial underpins a submitted NDA, but the FDA has advised the drug company previously 

that more than one trial would be required.   

Dovitinib’s Success was Material to Allarity 

22. Allarity is a biopharmaceutical company focused on pairing cancer drug 

candidates that have been abandoned or shelved by other companies with a genetic test Allarity 

developed, thus targeting patients most likely to benefit from a particular cancer drug.  One such 

drug candidate was dovitinib.  

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 6 of 21



 

 

7 

23.  Dovitinib originally was developed by another pharmaceutical company, 

Company A, for the treatment of advanced renal cell carcinoma, a particularly deadly form of 

kidney cancer.  Company A ceased developing dovitinib after a 2013 Phase III trial failed to 

show that dovitinib was more effective than (or superior to) a comparator drug (“the Dovitinib 

Trial”).  In 2018, Allarity licensed dovitinib from Company A. 

24. Dovitinib’s hoped-for approval by the FDA was material to Allarity because the 

company had yet to have a drug approved for sale to the public.  As a result, at all relevant times, 

the estimated likelihood of dovitinib’s success factored heavily into Allarity’s business 

prospects.  As Allarity itself acknowledged in 2021 public filings with the Commission, “[i]f we 

are unable to submit an NDA to the U.S. FDA for our therapeutic candidate dovitinib… or if we 

experience significant delays in doing so,” or “[i]f we are unable to… receive marketing 

approval for… dovitinib…our business could be substantially harmed.”   

Allarity is Admonished by the FDA  

25. In December 2019, Allarity requested a meeting with FDA staff to discuss 

Allarity’s analysis of the Dovitinib Trial data and the anticipated filing of the dovitinib NDA (the 

“FDA Meeting”).   

26. In correspondence ahead of the FDA Meeting, Allarity communicated to the FDA 

its plan to rely on a retrospective, non-inferiority analysis of PFS from the Dovitinib Trial and 

solicited the FDA’s feedback on various questions.  Although this plan contravened published 

FDA guidance, Allarity chose to rely on a non-inferiority analysis of PFS because the Dovitinib 

Trial had already failed to show dovitinib was superior to the comparator drug on either PFS or 

OS.  

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 7 of 21



 

 

8 

27. The FDA staff responded in writing on February 14, 2020, saying in the preamble 

of the written comments: “We do not agree with your plan to submit an NDA based on a 

retrospective non-inferiority analysis of a trial that failed to demonstrate superiority.  There are 

multiple issues with your proposal...”  The specific issues the FDA noted were Allarity’s 

proposal to 1) define the non-inferiority margin for its analysis after the Dovitinib Trial had 

already concluded and 2) analyze PFS rather than OS.  The FDA took issue with Allarity’s 

analysis because it was susceptible to manipulation for two reasons: one, Allarity was proposing 

to define the non-inferiority margin for its analysis after it already knew the results of the 

Dovitinib Trial; and two, Allarity was planning to assess the more subjective of the two study 

endpoints, PFS (rather than OS).   

28.  In responding to Allarity’s question, “Does the Agency agree that the proposed 

clinical data supporting the proposed safety and efficacy claims are adequate to support the 

submission of the NDA for the proposed indication?” the FDA responded, “No,” and referenced 

the preamble again.  In response to another Allarity question, “Does the Agency agree that this 

statistical approach is adequate to support the filing of dovitinib in the proposed indication?” the 

FDA also responded, “No.”  

29. For all eleven written questions posed by Allarity to the FDA, the FDA referenced 

back to the preamble in their responses, putting Allarity on notice that the FDA was highly 

unlikely to even accept the dovitinib NDA for substantive review, much less approve it.  

30. Carchedi, Foegh and Cullem each received a copy of the FDA’s written response 

on February 14, 2020.  

31. The next day, Allarity’s Chief Science Officer emailed Carchedi and Foegh to 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 8 of 21



 

 

9 

note that the FDA’s published guidance referenced in the FDA’s written response to Allarity 

appeared to be an “insurmountable hurdle” because it prohibited the exact analysis Allarity 

planned to use as the basis for the dovitinib NDA.  

32. On February 20, 2020, Allarity and FDA staff met in person.  Carchedi and Foegh 

attended the FDA Meeting along with various consultants Allarity had retained to advise it on its 

regulatory strategy.   

33. The official minutes of the FDA Meeting, which were created by FDA staff 

during the meeting, with Allarity employees and consultants present, summarized the parties’ 

main discussion points.  The minutes stated, in relevant part, “FDA reiterated that unplanned 

determination of non-inferiority following failure to show superiority would not suffice for 

demonstrating non-inferiority of dovitinib and that PFS is not an appropriate endpoint for a non-

inferiority trial.  The FDA recommended that [Allarity] prospectively plan and conduct a new 

trial”—the strongest language the FDA uses in meeting minutes.    

34. Foegh, Carchedi, and Cullem each received a copy of the official meeting minutes 

on March 18, 2020.  In an email to an Allarity consultant, Foegh described the minutes as “pretty 

negative in terms of filing” with “[n]early every answer to our questions [beginning] with Do not 

file the NDA.” 

35. Allarity’s consultants who attended the FDA Meeting took notes of their own.  

These notes also reflected the grim outcome of the FDA Meeting.  One set of notes 

memorialized that: 

a. “FDA essentially claimed that there was simply no efficacy (or, insufficient 

efficacy) with dovitinib” 

b. “sounded like FDA doesn’t want to see dovitinib get on the market,”  

c. “Several different times, and in different ways, FDA reiterated that the ‘non-

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 9 of 21



 

 

10 

inferiority approach’…was invalid….FDA further stated that the ‘use’ of PFS 

and the definition of disease progression was invalid for / impossible to use 

with an NI approach.” 

d. “the possible submission of an NDA was ‘delaying the inevitable.’” 

 

Foegh and Cullem received a copy of these notes on February 20, 2020, and February 22, 2020, 

respectively. 

36. A different consultant’s notes observed that: 

a. “FDA reiterated its position that the trial that the NDA is based upon did not 

demonstrate superiority and that [Allarity] cannot now use the data and apply 

it to non-inferiority trial.” [emphasis in original],  

b. “the [FDA] is asking [Allarity] not to submit the NDA,” and 

c. “FDA stated that they do not currently advise submitting an application[.]” 

Carchedi and Foegh received these notes on or about March 11, 2020.  

Defendants Schemed to Hide the FDA’s Recommendations   

37. Allarity issued a press release on March 20, 2020, purporting to update the public, 

including investors, on the outcome of the FDA Meeting.  Carchedi, Foegh and Cullem helped 

draft the press release, and Carchedi approved it.  The press release remained on Allarity’s public 

website through at least 2022. 

38. This press release painted a wholly inaccurate and incomplete picture of the FDA 

Meeting.  One, it falsely claimed, “FDA indicated that they would accept the [New Drug 

Application] filing if submitted, and provided additional guidance regarding the submission[.]” 

In actuality, Defendants knew, or were reckless in not knowing, the FDA had recommended 

against submitting the dovitinib NDA and had threatened not to accept it for filing.  

39. Two, the press release represented that: “[Allarity] plans to use the data from the 

[Dovitinib Trial] to prove that Dovitinib is in fact ‘non-inferior’ to [the comparison drug] for the 

treatment of [renal cell carcinoma], and expects that Dovitinib will be approved by the FDA as a 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 10 of 21



 

 

11 

safe and efficacious drug[.]”  This statement was false and misleading because Defendants knew, 

or were reckless in not knowing, that the FDA had outright rejected this plan and that dovitinib 

would not be approved on such data.  

40. Three, the press release stated that the FDA has “provided input on the ‘non-

inferiority’ margin” and “discussed progression free survival (PFS) as an endpoint for ‘non-

inferiority,’” but misleadingly omitted FDA’s actual input— i.e., that Allarity’s proposed 

analysis was invalid and unusable.  

41. Finally, the March 20, 2020, press release was misleading because it did not 

disclose the crux of the FDA’s feedback—the recommendation that Allarity conduct a new trial 

prior to submitting its NDA.  By omitting this information, Defendants misrepresented the 

strength of the dovitinib NDA and its likelihood of approval.   

42. Carchedi, Cullem and Foegh also misled Allarity’s Board of Directors.  On March 

30, 2020, only twelve days after Defendants received a copy of the strident FDA meeting 

minutes, Allarity’s Board met.   

43. Carchedi presented at the Board meeting.  According to the Board minutes, 

Carchedi falsely characterized the FDA Meeting as “positive”— withholding from the Board the 

FDA’s admonishment not to submit the dovitinib NDA and instead conduct a new trial. Cullem 

also attended the Board meeting as secretary, but did not disagree with Carchedi’s 

characterization or disclose the FDA’s actual feedback to the Board.   

44. Defendants were all regular presenters at Board meetings thereafter.  However, at 

no point before filing the dovitinib NDA in December 2021 did any of the Defendants alert the 

Board to the FDA’s forceful criticisms, despite dovitinib’s undeniable importance to Allarity’s 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 11 of 21



 

 

12 

business prospects.   

45. Defendants’ deception also extended to Company A, from which it had licensed 

dovitinib and which had signed a non-disclosure agreement with Allarity.  On February 16, 

2021, Company A requested a copy of the FDA Meeting minutes.  Rather than provide Company 

A with an unadulterated copy of the minutes pursuant to the non-disclosure agreement in place, 

Carchedi and Cullem undertook to redact any negative information from the minutes.  When 

Cullem circulated the proposed redactions internally on March 5, 2021, he explained, “I have 

redacted (blackout text) any of the FDA comments about unwillingness to accept non-inferiority 

etc.”  Cullem then sent Company A the heavily redacted version of the minutes on March 18, 

2021, copying Foegh. 

46. On August 23, 2021 and November 23, 2021, Allarity published on its website 

two “Interim reports,” one of which it also filed with the SEC, for the purpose of disclosing 

information about its proposed move from Denmark to the U.S. and the exchange of shares 

traded on the Swedish stock exchange for shares that would trade on the NASDAQ.  Carchedi 

helped draft, and signed, both reports.   

47. In the Interim reports, Allarity misrepresented that the FDA Meeting “provided 

guidance to the Company regarding its potential path to approval” and “[b]ased on this feedback 

from the FDA, Allarity plans to file a New Drug Application (“NDA”) for the approval of 

dovitinib . . .  during 2021” (emphasis added).  This was misleading because the FDA’s feedback 

had been not to submit the dovitinib NDA but instead to conduct a new trial.   

48. The interim reports also misrepresented dovitinib as having “shown identical 

clinical activity to [the comparator drug]” in the Dovitinib Trial.  This claim was misleading for 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 12 of 21



 

 

13 

three reasons: 1) Allarity’s post-hoc, non-inferiority analysis of the Dovitinib Trial did not even 

assess whether dovitinib had “identical clinical activity” to the comparator drug —a more 

exacting standard than non-inferiority; 2) it omitted that the Dovitinib Trial had failed to show 

dovitinib was superior to the comparator drug on either PFS or OS; and 3) it neglected to 

disclose that the FDA had rejected Allarity’s proposal to use the Dovitinib Trial to demonstrate 

dovitinib’s efficacy.   

49. In anticipation of listing Allarity stock on NASDAQ, on November 4, 2021, 

Allarity filed with the Commission a Form S-4 Registration Statement containing a prospectus.  

On December 16, 2021, Allarity filed with the Commission a Form S-1 Registration Statement 

containing a prospectus in connection with a $20 million investment from an investor, allowing 

that investor to offer and sell the Allarity shares it would receive in exchange for its investment 

in Allarity.  Carchedi signed both prospectuses. 

50. Both prospectuses touted dovitinib’s purported “therapeutic equivalence to” the 

already-approved comparison drug and claimed the Dovitinib Trial had “established that 

dovitinib is non-inferior to [the comparison drug] with respect to PFS and OS.”  This was 

misleading because Defendants knew, or were reckless in not knowing, that the FDA disagreed 

with these efficacy claims.   

51. Further, the December 16 prospectus provided the false assurance that “we 

anticipate…approval of our [NDA].”  Defendants knew, or were reckless in not knowing, that 

the dovitinib NDA would not be approved absent a new trial because the FDA had previously 

told Allarity that it did not agree with Allarity’s plan to submit an NDA based on a retrospective 

non-inferiority analysis of the Dovitinib Trial.  This same prospectus also listed the FDA’s 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 13 of 21



 

 

14 

requirements for drug approval based on retrospective analyses, but misleadingly failed to 

mention that the FDA had told Allarity that the proposed dovitinib NDA had not met such 

requirements.   

52. Throughout 2021, Allarity maintained and periodically updated a slide deck that 

Carchedi used in discussions with investors and prospective investors.  The Defendants each 

participated in preparing the deck.  In this slide deck, which was posted to Allarity’s website and 

filed with the Commission as an exhibit to Form 8-K on January 18, 2022, Allarity falsely 

claimed dovitinib’s efficacy had been demonstrated in a Phase III trial.  This was false and 

misleading because the FDA expressly advised Allarity that the Dovitinib Trial could not be used 

to demonstrate dovitinib’s efficacy for purposes of approval.  

53. The slide deck also misleadingly touted that the dovitinib NDA had selected renal 

cell carcinoma as the lead indication “. . . for fastest path to approval” (emphasis in original) of 

the dovitinib NDA, but omitted the FDA’s recommendation not to submit the dovitinib NDA at 

all and to instead conduct a new trial.  

54. Allarity provided a copy of the slide deck to a prospective investor in March 

2021, and to at least two prospective investors in October 2021.  Allarity ultimately raised $20 

million in December 2021 from a single investor in connection with these prospectuses and slide 

decks.   

Defendants Capitalize on the NDA Submission  

55. On December 21, 2021, Allarity submitted its NDA for dovitinib.  The NDA did 

not contain data from any second trial, as recommended by the FDA, and was premised on an 

after-the-fact, non-inferiority analysis of the Dovitinib Trial, which the FDA had warned Allarity 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 14 of 21



 

 

15 

against using.  Nevertheless, the press release Allarity issued on December 22, 2021, heralding 

the milestone did not disclose the FDA’s prior criticisms of the data, its admonishment not to 

submit the NDA, or its recommendation to conduct a new trial. Carchedi gave the final approval 

on this press release.   

56. Also on December 21, 2021, Allarity announced that it had secured $20 million in 

funding from a single investor and that its stock had begun trading on NASDAQ.   

57. For meeting certain goals, including submitting the dovitinib NDA and listing 

Allarity’s stock on the NASDAQ by the end of 2021, the Allarity Board awarded Carchedi a 

cash bonus of approximately $225,000, Foegh a cash bonus of approximately $132,000, and 

Cullem a cash bonus of approximately $119,000. All three also received stock option awards.   

Defendants’ Scheme Unravels 

58. On January 27, 2022, FDA staff and Allarity met by phone.  Foegh participated in 

the call.  Referring back to its statements from the FDA Meeting, FDA staff again advised 

Allarity that the dovitinib NDA was riddled with issues—each of which would render it 

unapprovable—and recommended Allarity withdraw the NDA. Allarity did not withdraw its 

NDA, but never disclosed to investors that the FDA had recommended withdrawal.  Carchedi 

and Cullem were informed of the outcome of the call later the same day.   

59. Then, on February 15, 2022, the FDA issued Allarity an RTF letter.  According to 

the letter, FDA declined to proceed with a substantive review of the dovitinib NDA because a 

retrospective, non-inferiority analysis of a failed superiority trial cannot be used to demonstrate 

PFS—the same warning the FDA had communicated to Allarity years before, at the in-person 

FDA Meeting in 2020.  

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 15 of 21



 

 

16 

60. When Allarity’s Chairman of the Board received a copy of the RTF letter, on or 

about February 18, 2022, he emailed Cullem saying, “I’m interested to know who advised us to 

file against the crystal clear advice of the FDA.”  Cullem and Carchedi explained in response 

that securing the $20 million investment in December 2021 had been crucial to Allarity avoiding 

bankruptcy and filing the NDA had been crucial to the investor providing funding.  

61. On February 18, 2022, Allarity, for the first time, publicly revealed a problem 

with its NDA, announcing its receipt of the RTF letter.  The press release, which was drafted, in 

part, by Carchedi and Cullem and approved by Carchedi, again concealed from investors that the 

FDA had threatened Allarity with this very outcome years before, in 2020.  

62. The next trading day the market reacted strongly, with Allarity’s stock price 

closing down approximately 31%—the largest one-day drop in the stock’s history up to that 

point.   

63. Then, in August 2022, Allarity announced it was no longer pursuing development 

of dovitinib as a stand-alone treatment for kidney cancer. 

FIRST CLAIM 

Fraud in the Purchase or Sale of Securities in Violation of 

Section 10(b) of the Exchange Act and Rule 10b-5 Thereunder 

(Against Carchedi) 

64. The Commission repeats and incorporates by reference the allegations in 

paragraphs 1- 63 above as if set forth fully herein. 

65. Carchedi engaged in a fraudulent course of conduct that included making material 

misrepresentations and omitting to state material facts necessary to make the statements made, in 

light of the circumstances under which they were made, not misleading regarding an FDA 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 16 of 21



 

 

17 

recommendation not to submit an NDA for dovitinib.  

66. By engaging in the conduct described above, Carchedi, directly or indirectly, 

acting knowingly or recklessly, by the use of means or instrumentalities of interstate commerce 

or of the mails, in connection with the purchase or sale of securities, has employed devices, 

schemes or artifices to defraud; made untrue statements of material fact or omitted to state 

material facts necessary to make the statements made, in light of the circumstances under which 

they were made, not misleading; and engaged in acts, practices or courses of business which 

operate as a fraud or deceit upon certain persons. 

67. By reason of the forgoing, Carchedi violated Section 10(b) of the Exchange Act 

[15 U.S.C. §78j(b)] and Rule 10b-5 thereunder [17 C.F.R. §240.10b-5]. 

SECOND CLAIM 

Fraud in the Offer or Sale of Securities in 

Violation of Section 17(a) of the Securities Act 

(Against Carchedi) 

68. The Commission repeats and incorporates by reference the allegations in 

paragraphs 1-63 above as if set forth fully herein. 

69. Carchedi engaged in a fraudulent course of conduct that included making material 

misrepresentations and omitting to state material facts necessary to make the statements made, in 

light of the circumstances under which they were made, not misleading regarding an FDA 

recommendation not to submit an NDA for dovitinib.  

70. By engaging in the conduct described above, Carchedi, directly or indirectly, 

acting knowingly, recklessly, or negligently, in the offer or sale of securities by the use of means 

or instrumentalities of interstate commerce or the mails, has employed devices, schemes or 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 17 of 21



 

 

18 

artifices to defraud; obtained money or property by means of untrue statements of material fact 

or the omission of a material fact necessary in order to make the statements, in light of the 

circumstances under which they were made, not misleading; and engaged in transactions, 

practices or courses of business which operate as a fraud or deceit upon purchasers of the 

securities. 

71. By reason of the forgoing, Carchedi violated Section 17(a) of the Securities Act 

[15 U.S.C. §77q(a)]. 

THIRD CLAIM 

Fraud in the Offer or Sale of Securities in 

Violation of Sections 17(a)(1) and (3) of the Securities Act 

(Against Cullem and Foegh) 

72. The Commission repeats and incorporates by reference the allegations in 

paragraphs 1-63 above as if set forth fully herein. 

73. Cullem and Foegh engaged in a fraudulent course of conduct regarding an FDA 

recommendation not to submit an NDA for dovitinib.  

74. By engaging in the conduct described above, Cullem and Foegh, directly or 

indirectly, acting knowingly, recklessly, or negligently, in the offer or sale of securities by the 

use of means or instrumentalities of interstate commerce or the mails, have employed devices, 

schemes or artifices to defraud; and engaged in transactions, practices or courses of business 

which operate as a fraud or deceit upon purchasers of the securities. 

75. By reason of the forgoing, Cullem and Foegh violated Sections 17(a)(1) and (3) of 

the Securities Act [15 U.S.C. §77q(a)(1) and (3)]. 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 18 of 21



 

 

19 

FOURTH CLAIM 

Fraud in the Purchase or Sale of Securities in 

Violation of Section 10(b) of the Exchange Act and Rules 10b-5(a) and (c) Thereunder  

(Against Cullem and Foegh) 

76. The Commission repeats and incorporates by reference the allegations in 

paragraphs 1-63 above as if set forth fully herein. 

77. Cullem and Foegh engaged in a fraudulent course of conduct regarding an FDA 

recommendation not to submit an NDA for dovitinib.  

78. By engaging in the conduct described above, Cullem and Foegh, directly or 

indirectly, acting knowingly or recklessly, in connection with the purchase or sale of securities, 

by the use of means and instrumentalities of interstate commerce, or of the mails, or of a national 

securities exchange have employed devices, schemes or artifices to defraud and have engaged in 

acts, practices or courses of business which operate as a fraud or deceit upon certain persons. 

79. By reason of the forgoing, Cullem and Foegh violated Section 10(b) of the 

Exchange Act [15 U.S.C. §78j(b)] and Rules 10b-5(a) and (c) thereunder [17 C.F.R. §240.10b-

5(a) and (c)]. 

PRAYER FOR RELIEF 

WHEREFORE, the Commission requests that this Court: 

A. Enter a permanent injunction restraining Defendants and each of their agents, 

servants, employees and attorneys and those persons in active concert or participation with them 

who receive actual notice of the injunction by personal service or otherwise, including facsimile 

transmission or overnight delivery service, from directly or indirectly engaging in the conduct 

described above, or in conduct of similar purport and effect;  

B. Require Defendants to disgorge their ill-gotten gains, plus pre-judgment interest; 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 19 of 21



 

 

20 

C. Require Defendants to pay an appropriate civil monetary penalty pursuant to 

Section 20(d) of the Securities Act [15 U.S.C. §77t(d)], and Section 21(d)(3) of the Exchange 

Act [15 U.S.C. §78u(d)(3)]; 

D. Impose an officer and director bar against Defendants pursuant to Section 20(e) of 

the Securities Act [15 U.S.C. §77t(e)] and Section 21(d)(2) of the Exchange Act [15 U.S.C. § 

78u(d)(2)]; 

E. Retain jurisdiction over this action to implement and carry out the terms of all 

orders and decrees that may be entered; and 

F. Award such other and further relief as the Court deems just and proper.  

       

              Respectfully submitted, 

SECURITIES AND EXCHANGE COMMISSION 

By its attorneys, 

 

/s/ Susan R. Cooke  

Susan R. Cooke (DC Bar No. 978173) 

David Fox (DC Bar No. 1686020 

Dawn Edick (Mass. BBO No. 641659) 

Attorneys for Plaintiff 

SECURITIES AND EXCHANGE COMMISSION 

33 Arch Street, 24th Floor 

Boston, MA  02110 

(617) 573-4538 (Cooke direct) 

(617) 573-4590 (fax) 

[email protected] (Cooke email) 

 

DATED: March 12, 2025 

 

 

 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 20 of 21



 

 

21 

CERTIFICATE OF SERVICE 

 

 I, Susan Cooke, hereby certify that this document was filed on this date through the ECF 

system and will be sent to the registered participants as identified on the Notice of Electronic 

Filing (NEF) as of the date of this filing. 

      /s/ Susan R. Cooke  

 

Dated:  March 12, 2025 

Case 1:25-cv-10599     Document 1     Filed 03/12/25     Page 21 of 21